An interventional study of Mindfulness-Based Therapy for Insomnia in Insomnia and Rumination, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment
The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.
Cognitive-behavioral therapy and pharmacotherapy are effective interventions for insomnia. Even so, about half of patients do not adequately respond to these treatments. Non-remission has been linked to high cognitive arousal that does not improve with traditional therapies. This study will examine the effects of mindfulness-based therapy for insomnia (MBTI) in a sample of patients who previously failed cognitive behavioral therapy and/or pharmacotherapy for insomnia.
This trial utilizes a single-arm, open label trial of MBTI. MBTI is delivered via telemedicine video in an individual therapy format.
Male and female participants who have insomnia, are age 18 and older, and who are recruited into the study will complete an initial assessment of their qualifications that are based on the severity of their insomnia symptoms, depression symptoms, and physical and mental health status. Eligible participants will undergo a clinical sleep interview and then complete 8 sessions of MBTI. Study outcomes are assessed via online survey before treatment, after treatment, and then a 6-month follow-up.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's enrollment of 21 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 24 (65%) have results posted.
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Exclusion Criteria:
Mindfulness-Based Therapy for Insomnia
Behavioral: Mindfulness-Based Therapy for Insomnia
Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.
Also known as: MBTI
Insomnia Severity Index
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)
Time frame: Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)
Five Facet Mindfulness Questionnaire-15 (FFMQ-15)
Five Facet Mindfulness Questionnaire - 15 (total scores ranges 15-75, with higher scores indicating someone who is more mindful in their everyday life.)
Time frame: Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion)
| Milestone | MBTI |
|---|---|
| Started | 21 |
| Completed | 19 |
| Not completed | 2 |
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)
| score on a scale | MBTI |
|---|---|
| Pre-treatment | 16.42 ± 3.95 |
| Post-treatment (7 weeks following initiation of treatment) | 8.37 ± 4.19 |
| 6 months follow-up (6 months following completion of treatment) | 11.72 ± 4.95 |
Five Facet Mindfulness Questionnaire - 15 (total scores ranges 15-75, with higher scores indicating someone who is more mindful in their everyday life.)
| score on a scale | MBTI |
|---|---|
| Pre-treatment | 52.95 ± 8.3 |
| Post-treatment | 57.42 ± 9.87 |
| 6 months follow-up | 55.50 ± 10.29 |
Collected over Subjects' self-report during treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MBTI | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
Patients with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report.
| Age, Continuous(years) | MBTI |
|---|---|
| Mean | 57.16 ± 14.69 |
| Sex: Female, Male(Participants) | MBTI |
|---|---|
| Female | 16 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | MBTI |
|---|---|
| Race/Ethnicity — Non-Hispanic White | 12 |
| Race/Ethnicity — Non-Hispanic Black | 7 |
| Race/Ethnicity — Others | 2 |
| Insomnia Severity Index(units on a scale) | MBTI |
|---|---|
| Mean | 16.42 ± 3.95 |
| Five Facet Mindfulness Questionnaire-15 (FFMQ-15)(units on a scale) | MBTI |
|---|---|
| Mean | 52.95 ± 8.30 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2020 to primary completion in Apr 2022, 19 months.
Results were first posted in Aug 2024, 2 years 4 months after primary completion.
Of 825 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 19 months is close to that.
Counting every sponsor, half of 883 studies reached it within 19 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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